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FACT


Malaria

Development of Oral Fixed Dose Artesunate-Based Combinations for the Treatment of Uncomplicated Malaria
Framework programme:
5
Project number:
ICA4-CT-2002-10046
EC contribution:
€ 1 163 698
Duration:
36 months
Type:
RS
Starting date:
1 July 2002

Summary:

This proposal aims at the fast-track pharmaceutical development and clinical validation of two artesunate-based fixed dose combinations for the treatment of malaria, including the preparation of relevant registration files. The goal is to make these new combination drugs available for use as quality, safe, viable, adapted and affordable drugs in the endemic countries. This project contributes a missing link in promoting antimalarial policy changes towards combination therapy, and the successful implementation thereof. It builds upon the expertise of R&D centres in the EU and different regions in the world, which are being mobilised in an international effort to improve dramatically the available malaria treatment tools.

Objectives:

Clinical trials and therapeutic experience have indicated that combinations of antimalarial drugs with different mechanisms of action, including artemisinin derivatives, improve therapy by preventing resistance. The success of the deployment of such drug combinations depends upon the availability of affordable fixed-dose combinations, adapted to the conditions of use. The proposal aims at promoting a therapeutic antimalarial policy change and the successful implementation thereof, by completing the development of quality, effective, safe, adapted and affordable fixed dose combinations of artesunate+mefloquine and artesunate+amodiaquine respectively. This will include preparing registration files and making the combination drug products available in the endemic countries by means of an international co-operation involving experts and institutes of the concerned countries.

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